Kornimate/medical-research-clean huggingface dataset:
intravenous lidocaine in children undergoing laparoscopic appendectomy

Conditions: Acute Appendicitis; Postoperative Pain; Postoperative Nausea and Vomiting

Summary: intravenous lidocaine - a potent local anesthetic with analgesic and anti-inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. in children population promising but limited evidence is available. the study was planned to evaluate the efficacy of continuous intravenous infusion of lidocaine to reduce opioid consumption during and after laparoscopic appendectomy in children.

postoperative pain in children is still one of the most under diagnosed and under treated medical problems. it affects post-surgery recovery, mortality and morbidity, limits mobility. untreated pain not only causes child's suffering but can decrease the pain threshold in the future or lead to the development of chronic pain. postoperative analgesia has been traditionally based on opioids but as their use can be associated with adverse effects prolonging hospital stay and affecting recovery current guidelines focus on multimodal approaches involving numerous analgesics with different mechanism of action. growing evidence suggests that intravenous lidocaine reduces intra- and postoperative requirement for opioids. lidocaine has been proved to have analgesic and anti-inflammatory properties. it is also a potent peripheral nervous system modulator inhibiting peripheral and central sensitization. the studies performed in adult population have proved the efficacy of systemic lidocaine in postoperative pain treatment. it is an effective adjunct that reduces opioids consumption and facilitates pain management. as such lidocaine infusion has been included in postoperative pain management guidelines for adults. studies on children population have promising results but high quality randomized controlled trials are still missing. the proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving fentanyl and sevoflurane) in reducing opioids consumption and facilitating postoperative pain control in children undergoing laparoscopic appendectomy.

Eligibility criteria:
inclusion criteria: 1. age between 18 months and 18 year-old 2. patients with american society of anaesthesiologists physical status (asa) class 1/1e, 2/2e, 3/3e 3. patients undergoing laparoscopic appendectomy exclusion criteria: 1. allergy to local anesthetics or contraindication to use of lidocaine 2. patients with american society of anaesthesiologists physical status (asa) iv or more. 3. severe cardiovascular disease 4. preoperative bradycardia 5. preoperative atrioventricular block 6. renal failure 7. chronic treatment with analgesics 8. parents' refusal

Keywords: systemic lidocaine nalbuphine postoperative pain multimodal analgesia laparoscopic appendectomy laparoscopy recovery
safety and efficacy study of the neurent medical neuromark™ system in subjects with chronic rhinitis

Conditions: Chronic Rhinitis

Summary: a randomized, sham-controlled, double-blind study of the neuromarktm system as a treatment for chronic rhinitis

the meridien study is a prospective, multi-center, double-blind, randomized (1:1), sham-controlled, cross-over study to evaluate the safety and efficacy of the neuromark™ system in patients with chronic rhinitis.

Eligibility criteria:
inclusion criteria: * subject provides written informed consent, including authorization to release health information. * subject is 18 years of age or older at the time of consent. * subject has provided a negative pregnancy test (if subject is a woman of childbearing potential (wocbp). * subject wocbp must be practicing and willing to continue an effective method of birth control during the course of the study. * subjects stated willingness to comply with all study procedures, post- treatment care and availability for the duration of the study follow up of 1 year. * subject tests negative for active covid-19 at the start of study screening and continues to be free from covid-19 symptoms until the time of enrollment/treatment. * subject understands and agrees to follow local covid-19 restrictions (social distancing, face mask, etc.) exclusion criteria: * subject has an allergy or intolerance to anaesthetic agent or other study-required materials. * subject is an active smoker or has been a smoker within the last 6 months (patient reported). * any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk to the study subject. * subject is pregnant, nursing or plans to become pregnant during the study, or is a wocbp, but is not willing to use an effective method of birth control. * patient is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the investigator would interfere with the study results * patient presents with any condition or situation which, in the investigator's opinion, puts the subject at risk, could confound the study results, or may interfere significantly with the subject's participation in the study.

Keywords: rhinitis
trial comparing 3 and 4 week regimen of gemcitabine and cisplatin in patients with lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate response rate of the 3 week versus 4 week treatment of gemcitabine with cisplatin as the first line treatment for non-small cell lung cancer patients in china.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of nsclc * presence of stage iiib or stage iv disease * patients must have received no prior systemic chemotherapy * patients must have at least one bi-dimensionally measurable lesion with clearly defined margins and two perpendicular diameters that are clearly measurable by any of the following: chest x-ray, with at least one diameter 1.0 cm or greater, ct, with both diameters greater than the distance between cuts of the imaging study, palpation, with both diameters 2.0 cm or greater, or disease progressing in areas of prior radiation therapy may be included * no prior radiotherapy for the target organ, no other radiotherapy for at least 2 weeks prior to study enrollment and the patient must have fully recovered from all acute toxic effects of the treatment. exclusion criteria: * are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * are employed by lilly (that is, employees, temporary contract workers, or designees responsible for the conduct the study). immediate family of lilly employees may participate in lilly sponsored clinical trials, but are not permitted to participate at a lilly facility. immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * have previously completed or withdrawn from this study or any other study investigating gemcitabine.
antimicrobial therapy for ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: the aim of this randoized controlled pilot study is to find a better treatment strategy for active uc based on the recent knowledge regarding the microbiota in uc and the beneficial or detrimental effects of antibiotics in restoring gut health and reducing inflammation. this study is designed to determine whether therapy with two antibiotics during a flare - amoxicillin and doxycillin, will be better than the current published antibiotic treatment combination using these antibiotics with metronidazole ( as the latter which may degrade beneficial species without adding benefit towards reducing pathobionts)

recent studies suggest that uc is associated with alterations of the microbiota. further support for targeting the microbiota includes several studies demonstrating that antibiotics might be helpful for severe refractory colitis. antibiotics may work by reducing pathobionts, by causing niche expansion of beneficial bacteria , and may harm if they do not reduce pathobionts or reduce beneficial commensals recently, a triple antibiotic therapy with amoxicillin, metronidazole and tetracycline was developed for uc. however, a recent study on the effect of 11 different oral antibiotics on gut bacteria found that seven of them including metronidazole might cause lbacterial translocation . anaerobes are critical for butyrate production. . based on these recent studies, it would appear that tetracycline and amoxicillin are more likely to cause the beneficial effect, while metronidazole might actually be detrimental. thus by removing metronidazole the investigators might actually have a better effect both for efficacy and safety.

Eligibility criteria:
inclusion criteria: 1. established diagnosis of uc, disease confined to the large intestine, involving the rectosigmoid for at least 3 months. 2. weight \>30 kg 3. mild to moderate active disease, sccai of ≥5 and ≤ 10, 10 ≤ pucai ≤4. 4. refractory to mesalamine 6 weeks, or steroids \> 14 days, or immunomodulator 12 weeks or biologics at least 12 weeks therapy. exclusion criteria: 1. start of a new biologic in the previous 12 weeks. 2. proctitis 3. evidence for clostridium difficile infection. 4. any proven current infection such as cmv, positive stool culture or parasite. 5. current extra intestinal manifestation of uc such as active arthritis or psc. 6. immune deficiency (other than drug induced). 7. current use of a calcineurin inhibitor 8. pregnancy. 9. suspected toxic megacolon, guarding on palpation, or signs of peritoneal inflammation 10. patients with other ibd unrelated disease such as autoimmune disorders, renal failure, fever or current infection (uti, strep throat, pneumonia, etc), prior or current neoplasia 11. fever \>38 12. participation in another clinical interventional trial 13. an active malignant disease or a prior malignancy during the previous 5 years (excluding skin bcc). 14. anticipation for antibiotic use within the study period (such as for elective surgery or dental treatment). 15. acute severe uc in the past 3 months. 16. presence of a pouch or pouchitis.

Keywords: ulcerative colitis
monocanalicular versus bicanalicular intubation in the treatment of congenital nasolacrimal duct obstruction

Conditions: Nasolacrimal Duct Obstruction

Summary: the aim of the study was to compare the success rate of monocanalicular intubation versus bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children aged between 10 and 36 months.

in a prospective, nonrandomized comparative study, the monocanalicular intubations (mci; n=35 eyes) through the inferior canaliculus or bicanalicular intubations (bci; n=35 eyes) were performed under general anaeshesia in children between 10 and 36 months of age suffering from congenital nasolacrimal duct obstruction (cnldo). the tubes were removed 3-4 months after the tube placement. thereafter, the children were followed up for 6 months after the removal of tubes. the therapeutic success was defined as the fluorescein dye disappearance test grade 0-1 corresponding with a complete resolution of previous symptoms. the partial success was defined as improvement with some residual symptoms. the complete and partial improvement was achieved in 31/35(88.57%) in group i with bci and in 34/35 (97.14%) in group ii with mci, respectively, and it was not significantly higher (p=0,584). complications occurred in both groups. dislodgement of the tube and premature removal was observed in four cases in group i (bci), the loss of the tube was observed twice in group ii with mci.. canalicular slitting was observed in 5 eyes in the group with bci. granuloma pyogenicum observed in 2 cases with mci revealed in a few weeks after the tube removal. corneal erosion in the inferior medial quadrant was observed in 1 eye with mci and revealed in a few days after the local treatment without tube removal. conclusions: both mci and the bci are effective methods how to treat cnldo. the advantage of the mci shows the lower incidence of the canalicular slit and easy placement.

Eligibility criteria:
inclusion criteria: * congenital nasolacrimal duct obstruction (cnldo) * resistance to a conservative therapy and/or probing exclusion criteria: - children younger than 10 months of age

Keywords: congenital nasolacrimal duct obstruction monocanalicular intubation bicanalicular intubation complications
a randomized, open-label, three-arm study of mzrw on tolerability, exposure and pharmacokinetics

Conditions: Functional Constipation; Gastrointestinal Disorders

Summary: this is a randomized open-label, three-arm, phase 1 clinical study. the investigators aim to investigate a chinese proprietary medicine, mzrw on its tolerability, system exposure and pharmacokinetics profile.

this is a randomized, open-label, three-arm study. the participants will be enrolled and randomized in a ratio of 1:1:1 to receive 5.0g, 7.5g, 10g b.i.d. of mzrw at 9 am respectively. the study drug, mzrw will be administrated to the participants by site personnel after participants have fasted overnight for more than 8 hours and 6 hours after administration. each participant will consume a standardized meal. in addition, the participants refrain from semen cannabis sativae, semen pruni armeniacae, radix paeoniae, fructus immaturus citri aurantii, cortex magnoliae and radix et rhizoma rhei foods for 3 days before the study until completion of the study. blood samples (5 ml each) will be collected from the medial cubital vein into evacuated tubes containing heparin just before and at 0.25, 0.5, 1, 2, 4, 8, 12h after administration and were immediately centrifuged (1700g, 10 min). plasma fractions were stored at -20°c until analysis. all study procedures conduct in accordance with the ethical principles of the declaration of helsinki, consistent with good clinical practice guidelines, and approved by hong kong baptist university ethics committee on the use of human subjects for teaching and research. subjects will be given their written informed consent before participating in the study. urine samples (50 ml each) will be collected the day before the administration and at 0 to 3h, 3 to 6h, 6 to 9h and 9 to 12h after administration. plasma and urine fractions will be stored at -80°c until analysis.

Eligibility criteria:
healthy voluteers

Keywords: randomized open-label study chinese herbal constipation/drug therapy
step trial for heel fat pad syndrome

Conditions: Heel Fat Pad Syndrome

Summary: the primary objectives of this study are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (hfps). for mechanistic understanding of the effect of the loop taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness.

the study objectives are to investigate the immediate and short-term effect of heel fat pad loop taping (experimental intervention) vs. control taping (control intervention) on pain and function in individuals with heel fat pad syndrome (hfps). we hypothesize that the fat pad loop taping is superior to control taping in immediate and short-term pain reduction and short-term function and mobility improvement. to understand potential mechanisms underlying the benefits of the looping taping, we will assess the immediate effect of taping on the pressure pain threshold and heel fat pad thickness. we hypothesize that applying fat pad loop taping will increase the pressure pain threshold (i.e., diminished pain sensitivity) recorded by a mechanical pressure algometer and increase fat pad thickness quantified by ultrasound. despite being the second leading cause of plantar heel pain, rcts for conservative management do not exist. findings of this proposed project will provide much-needed evidence on effective non-pharmacological managements of hfps.

Eligibility criteria:
inclusion criteria: * men or women 18 to 79 years of age * history of plantar heel pain in either foot for at least one week and less than 3 years before enrollment * tenderness on palpation of the heel fat pad * self-reported worst unilateral or bilateral central heel pain of ≥ 3 on a 0-10 numeric pain rating scale (nprs) during the past week * pain ≥ 3 on nprs during at least one of two pain-aggravating activities of 30-sec static single leg standing or barefoot 20-meter walking assessed during the enrollment screening and before the tape application exclusion criteria: * primary diagnoses of plantar heel pain (e.g., plantar fasciopathy, posterior tibialis tendinopathy, or tarsal tunnel syndrome) other than hfps * ultrasound-measured plantar fascia thickness ≥ 4mm, combined with clinical presentations of plantar fasciopathy * bmi ≥ 35 * systemic inflammatory arthritis * diabetes * lumbar radiculopathy * neurological conditions affecting gait and mobility * having received taping for hfps within the last month * prior heel surgery
prove of concept study, to evaluate the efficacy, safety, and tolerability of iberogast in the treatment of bowel troubles in patients with parkinson's disease

Conditions: Gastrointestinal Disorders in Parkinson's Disease

Summary: the main objective of this study is to evaluate the efficacy of stw5 iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.

gastrointestinal disorders are the most common non-motor symptoms of parkinson's disease (pd). they affect the entire intestinal tract and include excess saliva stasis (70% of patients), dysphagia (52%), gastroparesis (34-45%), and constipation. gastroparesis participates in dyspepsia and abdominal pain. constipation, as defined by the international standards criteria of rome iii, is present in 59% of pd patients and leads to functional impairment in 70% of patients. the mechanism underlying constipation is multifactorial and may include slow transit and defecation disorders secondary to anorectal dysfunction. bowel disorders are present in the early stage of the disease and usually precede the onset of motor symptoms. they may result from lesions of the enteric nervous system, of the autonomic nervous system, and from probable alterations in gastrointestinal motility controlled by the central nervous system. the stw5 (iberogast, steigerwald, germany) is a herbal agent composed of nine plant extracts, with prokinetic, antispasmodic, prosecretory, anti-inflammatory and anti-oxidant properties. these properties have been demonstrated in animals and in human pathology, in the treatment of dyspepsia and irritable bowel syndrome. it is the only phytotherapeutic agent which efficacy was demonstrated by randomized double-blind trials in these indications. in pd, the stw5 could improve constipation due to its prokinetic effects of the prosecretory enteric neurons. it could also improve dyspepsia and abdominal pain by its antispasmodic properties. we propose to study the efficacy and the safety of stw5 on bowel dysfunction in parkinsonian patients, especially on constipation.

Eligibility criteria:
inclusion criteria: * patient 30 to 80 years * parkinson's disease according to the criteria of the united kingdom parkinson's disease society brain bank * presence of constipation defined by the rome iii criteria functional constipation * social assured patient * patients with signed consent exclusion criteria: * organic affection colic * constipation drug * other neurological disorder parkinson's disease * metabolic disease diabetes collagenoses * severe renal or hepatic impairment * pregnant or lactating women * premenopausal women without contraceptive device effective * regular and prolonged use of history (\> 12 months) of laxatives irritants * use of oral laxative treatment in the two weeks before the start of treatment, and refusal to stop these treatment during the course of the study * taking treatment antabuse * cognitive impairment compromising understanding or application instructions * patient already included in a research protocol * minors * nobody protected by law
multicenter rct of adv-tk gene therapy improving the outcome of liver transplantation for advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: compare the effect of liver transplantation (lt) plus adv-tk gene therapy versus lt only in advanced primary hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * 18 - 65 years of age (male and female). * clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation. * patients who had unresectable hcc with single tumor diameter \> 5 cm and ≤ 10cm; or numbers of multiple tumors \>3 and ≤ 5, and the total length of foci diameter ≤ 15 cm. * serum afp ≤ 10000 ng/ml before liver transplantation. * child-pugh a-b. * no metastasis in extrahepatic main vescular and extrahepatic lymph node detected during the operation and no metastasis of other organs. * provide written informed consent before screening. exclusion criteria: * metastasis in extrahepatic organs. * hcc with invasion in extrahepatic main vescular and extrahepatic organs. * contraindications of operation of other organ system. * hypersensitivity to adenovirus, gcv or similar drugs. * serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%). * plan to accept clinical trials of other antitumor drugs. * immunological deficit. * hbsag(+) and hbcab(+) donor. * unsuitable participate assessed by investigator.